阿奇霉素与阿莫西林或阿莫西林克拉维酸治疗下呼吸道感染效果的Meta分析

Azithromycin versus amoxicillin or amoxicillin/clavulanate for lower respiratory tract infection:A Meta-analysis of randomized controlled trials

目的:比较阿奇霉素和阿莫西林或阿莫西林克拉维酸治疗下呼吸道感染的疗效和安全性。方法:检索英文数据库Cochrane library、Embase、MEDLINE、Pubmed;中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(维普)和万方数字化期刊全文库,手工检索相关会议的中英文论文集。纳入比较阿奇霉素和阿莫西林或阿莫西林克拉维酸治疗下呼吸道感染的疗效和安全性的随机对照试验(RCT),评价纳入研究的内部真实性。检索时间从建库至2013年6月,并采用Review Manager 5.2进行Meta分析。结果:共纳入18个RCT,共3 365例患者。Meta分析结果显示,阿奇霉素在治疗下呼吸道感染方面的疗效与阿莫西林或阿莫西林克拉维酸等效[RR=0.93,95%CI(0.55,1.55),P=0.77]。口服给药途径与注射给药途径对两药疗效影响差异无显著性。相对不同适应证,阿奇霉素在急性支气管炎治疗中的作用优于阿莫西林组,疗效结果具有显著性差异[RR=0.54,95%CI(0.38,0.77),P=0.000 6],在治疗慢性支气管炎急性加重和社区获得性肺炎的结果分别为[RR=1.29,95%CI(0.42,3.94),P=0.66]和[RR=0.80,95%CI(0.41,1.56),P=0.51],阿奇霉素组与阿莫西林组疗效相当。用于成人治疗下呼吸道感染时,两药的疗效无统计学意义[RR=1.17,95%CI(0.61,2.25),P=0.64],用于儿童时,阿奇霉素优于阿莫西林或阿莫西林克拉维酸,2组间疗效有统计学差异[RR=0.49,95%CI(0.29,0.82),P=0.007]。阿奇霉素采用的3种不同给药方案均对疗效结果无显著性影响。纳入文献中分配隐藏证据是否充分不影响最终疗效结果。阿奇霉素的细菌清除率略高于阿莫西林或阿莫西林克拉维酸,但差异并无统计学意义[RR=0.75,95%CI(0.55,1.02),P=0.07]。结论:阿奇霉素单药用于下呼吸道感染治疗时,与阿莫西林或阿莫西林克拉维酸有相似的疗效和细菌清除率,在急性支气管炎患者和儿童患者中显示了更好的优越性。

OBJECTIVE To compare the effectiveness and safety of azithromycin versus amoxicillin or amoxicillin/clavulanate for the treatment of patients with lower respiratory tract infection. METHODS The Cochrane Library, EMbase, MEDLINE, Pubmed, CNKI, CMJD and WANFANG data were electronically searched. Some relevant journals were also handsearched. The search time was from established data to June 2013. Randomized controlled trials of azithromycin versus amoxicillin or amoxicillin/clavulanate for lower respiratory tract infection were included. Meta-analyses were performed for the re suhs of homogeneous studies using the Cochrane Collaboration＇s RevMan 5.2 software. RESULTS A total of 18 randomized controlled trials involving 3 365 patients with lower respiratory tract infection were included. The results indicated that there was no significant difference between azithromycin or amoxicillin/clavulanate groups in treatment of lower respiratory infection [RR = 0. 93, 95%CI（0. 55,1.55）, P = 0. 771. There was no significant difference between their routes of administration. For the different indications, azithromycin played a more significant role in the therapy of acute bronchitis ERR = 0. 54, 95 % CI （0. 38,0. 77） ,P = 0. 00061. But there was no difference in therapy of exacerbations of chronic bronchitis [-RR = 1.29, 95% CI （0. 42,3.94） ,P = 0. 661 and community-acquired pneumonia ERR= 0. 80, 95%CI （0. 41,1.56）, P = 0. 511. The clinical effica cy of azithromycin in children [-RR= 0. 49,95%CI（0. 29,0. 82） ,P = 0. 0071 was superior to that in adults[-RR = 1.17, 95 % CI （0. 61,2. 25） ,P = 0. 641. There was no significant difference between the clinical efficacy considering the allocation concealment and dose regimen of azithromycin.. Azithromycin seems to have a higher eradication of organism compared with amoxicillin or amoxicillin/clavulanate. But there was no significant difference [-RR = 0. 75, 95% CI （0. 55,1.02）, P = 0. 071. CONCLUSION There appears an equal result of clinical efficacy and eradication of organism in treating lower respiratory tract infection between azithromycin and amoxicillin/elavulanate. However, in patients with acute bronchitis and children, azithromycin is superior to amoxicillin or amoxieillin/clavulanate.